- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03229304
Prediction of Postpartum Hemorrhage With Uterine Artery Doppler Measurement
July 21, 2017 updated by: Kerem Doga Seckin, Kanuni Sultan Suleyman Training and Research Hospital
The Role of Uterine Artery Doppler Measurement to Predict the Amount of Postpartum Hemorrhage in Low Risk Term Pregnancy
The aim of the study is to evaluate the uterine artery doppler just before labour in term low risk pregnancies.
And to investigate with this measurement if investigators could foreseen the amount of postpartum hemorrhage looking at decreased in the hematocrit values.
Study Overview
Study Type
Observational
Enrollment (Actual)
800
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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İstanbul, Turkey
- Kerem Doga Seckin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
The pregnant women that is term and have no risk factors for postpartum hemorrhage
Description
Inclusion Criteria:
- singleton term pregnancies
Exclusion Criteria:the pregnant women who have
- polyhydramnios
- Large for gestational age fetuses
- multiple pregnancies
- preterm labour
- chorioamnionitis
- history of atonia or postpartum hemorrhage
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To measure the uterine artery Pulsatility index in term pregnant women
Time Frame: 6-8 hour before the delivery
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With ultrasonography uterine artery doppler Pulsatility index (cm/s) will be measure
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6-8 hour before the delivery
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To measure the uterine artery Resistant index (cm/s) in term pregnant women
Time Frame: 6-8 hour before the delivery
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With ultrasonography uterine artery doppler Resistant index will be measure
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6-8 hour before the delivery
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To measure the uterine artery mean systolic/diastolic volume (cm/s) in term pregnant women
Time Frame: 6-8 hour before the delivery
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With ultrasonography Uterine artery doppler Mean systolic/diastolic volume (cm/s) ) will be measure
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6-8 hour before the delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kaplanoglu M, Karateke A, Un B, Gunsoy L, Baloglu A. Evaluation of uterine artery recanalization and doppler parameters after bilateral uterine artery ligation in women with postpartum hemorrhage. Int J Clin Exp Med. 2015 May 15;8(5):7823-9. eCollection 2015.
- Yildirim D, Ozyurek SE, Ekiz A, Eren EC, Hendem DU, Bafali O, Seckin KD. Comparison of active vs. expectant management of the third stage of labor in women with low risk of postpartum hemorrhage: a randomized controlled trial. Ginekol Pol. 2016;87(5):399-404. doi: 10.5603/GP.2016.0015.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
July 14, 2017
First Submitted That Met QC Criteria
July 21, 2017
First Posted (Actual)
July 25, 2017
Study Record Updates
Last Update Posted (Actual)
July 25, 2017
Last Update Submitted That Met QC Criteria
July 21, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12341
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Columbia UniversityCompletedHemorrhage, PostpartumUnited States
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Chelsea and Westminster NHS Foundation TrustCompleted
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